Raul Soto  Biol516
 System of checks and balances to ensure product:  Safety  Effectiveness
   All domestic and foreign    manufacturers of medical devices    intended for sale in the US must    have a quality sys...
A. General provisionsB. Quality System   Requirements, including   Management responsibility,   Quality Audits, and   Pers...
H. Product Acceptance for   incoming, in-process, and   finished productsI. Controlling nonconforming   productJ. Institut...
•   Plan for investigators toFO O D A N D DRUG                                           follow when evaluating a         ...
Corrective &             PreventiveDesign        Actions         Production &Controls                     Process Controls...
•   QSIT instructs auditors to    focus on four (4) subsystems:    • Management    • Design control    • Corrective and Pr...
   The other subsystems are covered through links    with the four main subsystems:     Records, Documents and Change Co...
A.   General provisionsB.   Quality System Requirements, including     Management responsibility, Quality Audits,     and ...
   Covers:     Management Responsibility (820.20)     Quality Audits (820.22)     Training (820.25)
   Quality Policy must exist   Management representative appointed as the    owner and responsible person for the Qualit...
   Covers:     Design Controls (820.30)     Production and Process Changes (820.70)     Device Master Record (820.181)...
   Design inputs or requirements for device are identified   Design outputs or specifications for device are    identifi...
   Design Review     Are the design requirements adequate?     Does the design meet these requirements?   Design Verif...
   Device design must be reviewed throughout    development to ensure all requirements are met   Example:     Design of...
 Compilation of records containing all  procedures and specifications for a finished  device Documents how to perform al...
 One for each device type Include or refer to all documents that can  demonstrate that the device has been designed  as ...
   Covers:     CAPA (820.100)     Nonconforming product (820.90)     Complaints (820.198)     Servicing (820.200)    ...
   CAPA procedures established   Management review of CAPA activities   Data sources (customers, manufacturing, etc.)  ...
   Covers:     Purchasing Controls            Receiving, in-process, and      (820.50)                        finished ...
   Manufacturing processes validated , controlled    and monitored   Software validated   Equipment is adjusted, calibr...
 Standard Operating Procedures (SOPs) Standard Quality Assurance Procedures  (QAPs) Some examples:    Complaint handli...
   All changes or    modifications to a device    must be documented   Manufacturer must    provide documented    eviden...
   Company must have a Quality    System in place   FDA audits quality systems based on    subsystems framework   Manag...
Elements of a Quality System for Medical Devices
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Elements of a Quality System for Medical Devices

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Elements of a Quality System for Medical Devices

  1. 1. Raul Soto Biol516
  2. 2.  System of checks and balances to ensure product:  Safety  Effectiveness
  3. 3.  All domestic and foreign manufacturers of medical devices intended for sale in the US must have a quality system
  4. 4. A. General provisionsB. Quality System Requirements, including Management responsibility, Quality Audits, and Personnel requirementsC. Design ControlsD. Document ControlsE. Purchasing ControlsF. Product identification and traceability at all stages of productionG. Controlling and defining production and process, including validation
  5. 5. H. Product Acceptance for incoming, in-process, and finished productsI. Controlling nonconforming productJ. Instituting corrective and preventive action when errors occurK. Labeling and packaging controlsL. Handling, storage, distribution and installationM. Records; including the Device Master record, Device History recordN. ServicingO. Statistical techniques
  6. 6. • Plan for investigators toFO O D A N D DRUG follow when evaluating a Medical DeviceA DM I N I STRA TI O N GUIDE TO INSPECTIONS OF manufacturer’s compliance QUALITY SYSTEMS with Quality Systems regulations August 1999
  7. 7. Corrective & PreventiveDesign Actions Production &Controls Process Controls ManagementMaterial Equipment &Controls Facility Controls Records, Documents, & Change Controls
  8. 8. • QSIT instructs auditors to focus on four (4) subsystems: • Management • Design control • Corrective and Preventive Actions • Production and Process Control
  9. 9.  The other subsystems are covered through links with the four main subsystems:  Records, Documents and Change Control  Throughout ALL the main subsystems  Facility and Equipment Control  Material control  Covered through Production and Process Control
  10. 10. A. General provisionsB. Quality System Requirements, including Management responsibility, Quality Audits, and Personnel requirementsC. Design ControlsD. Document ControlsE. Purchasing ControlsF. Product identification and traceability at all stages of productionG. Controlling and defining production and process, including validationH. Product Acceptance for incoming, in-process, and finished productsI. Controlling nonconforming productJ. Instituting corrective and preventive action when errors occurK. Labeling and packaging controlsL. Handling, storage, distribution and installationM. Records; including the Device Master record, Device History recordN. ServicingO. Statistical techniques
  11. 11.  Covers:  Management Responsibility (820.20)  Quality Audits (820.22)  Training (820.25)
  12. 12.  Quality Policy must exist Management representative appointed as the owner and responsible person for the Quality System Management reviews of the Quality System take place Quality audit procedures Quality system procedures Quality audits take place periodically
  13. 13.  Covers:  Design Controls (820.30)  Production and Process Changes (820.70)  Device Master Record (820.181)  Statistical Techniques (820.250)
  14. 14.  Design inputs or requirements for device are identified Design outputs or specifications for device are identified Design Review, Verification and Validation Software validation Risk analysis Design transfer to manufacturing completed successfully Device Master Record (DMR), and Design History File (DHF)
  15. 15.  Design Review  Are the design requirements adequate?  Does the design meet these requirements? Design Verification  Do the design outputs (specifications) meet the design inputs (requirements)? Design Validation  Do the design outputs (specifications) meet the device’s intended use?
  16. 16.  Device design must be reviewed throughout development to ensure all requirements are met Example:  Design of a portable defibrillator must take into account factors such as: • Storage temperatures in an ambulance • Shock and vibrations on the road • Electromagnetic interference from communication devices, other medical equipment, even the ambulance siren
  17. 17.  Compilation of records containing all procedures and specifications for a finished device Documents how to perform all specific functions related to the production of a device Some examples:  Device Design Specification  Device and part drawings  Manufacturing, Inspection and Testing procedures  Software  Label artwork
  18. 18.  One for each device type Include or refer to all documents that can demonstrate that the device has been designed as per an approved design plan Also include records and results of  Design review  Design verification  Design Validation  Change control
  19. 19.  Covers:  CAPA (820.100)  Nonconforming product (820.90)  Complaints (820.198)  Servicing (820.200)  Statistical Techniques (820.250)
  20. 20.  CAPA procedures established Management review of CAPA activities Data sources (customers, manufacturing, etc.) analyzed to identify nonconforming product and quality problems Statistical analysis across data sources Investigations conducted to identify root cause of failures Nonconforming product controlled, segregated Appropriate corrective actions and preventive actions carried out
  21. 21.  Covers:  Purchasing Controls  Receiving, in-process, and (820.50) finished device acceptance (820.80)  Identification (820.60)  Acceptance status (820.86)  Traceability (820.65)  Device handling (820.140)  Production and Process Controls (820.70)  Device labeling (820.120)  Inspection, measuring, and  Device storage (820.150) test equipment (820.72)  Device distribution (820.160)  Process Validation (820.75)  Device Installation (820.170)
  22. 22.  Manufacturing processes validated , controlled and monitored Software validated Equipment is adjusted, calibrated and maintained periodically What happens to rejects or nonconforming product Production employees trained and qualified Suppliers must be certified, audited
  23. 23.  Standard Operating Procedures (SOPs) Standard Quality Assurance Procedures (QAPs) Some examples:  Complaint handling  Maintenance  Calibration  Training  Change Control  Cleaning  Safety
  24. 24.  All changes or modifications to a device must be documented Manufacturer must provide documented evidence of whether a change alters the device’s effectiveness or safety If there are differences in effectiveness or safety then the manufacturer must file a 510(k) or PMA supplement
  25. 25.  Company must have a Quality System in place FDA audits quality systems based on subsystems framework Management involvement is vital Design, Production, Purchasing, Equipment, must be in state of control Investigate, correct, prevent non- conformances Change control Documentation!

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